11.100 : Laboratory medicine

11.100.01

Laboratory medicine in general

11.100.10

In vitro diagnostic test systems

11.100.20

Biological evaluation of medical devices

11.100.30

Analysis of blood and urine

11.100.99

Other standards related to laboratory medicine
UNE-EN ISO 14155:2021

UNE-EN ISO 14155:2021

Active Most Recent

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2020)

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UNE-EN ISO 10993-1:2021

UNE-EN ISO 10993-1:2021

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Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)

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UNE-EN ISO 17511:2022

UNE-EN ISO 17511:2022

Active Most Recent

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

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UNE-ISO 15190:2022

UNE-ISO 15190:2022

Active Most Recent

Medical laboratories — Requirements for safety

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UNE-EN ISO 6717:2022

UNE-EN ISO 6717:2022

Active Most Recent

In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

€69.00

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UNE-EN ISO 10993-7:2009/A1:2022

UNE-EN ISO 10993-7:2009/A1:2022

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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019)

€53.00

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UNE-EN ISO 15189:2023

UNE-EN ISO 15189:2023

Active Most Recent

Medical laboratories - Requirements for quality and competence (ISO 15189:2022)

€129.00

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UNE-ISO 35001:2021/Amd 1:2024

UNE-ISO 35001:2021/Amd 1:2024

Active Most Recent

Biorisk management for laboratories and other related organisations — Amendment 1: Climate action changes

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ASTM D7427-16

ASTM D7427-16

Superseded Historical

Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex

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ASTM D6499-16

ASTM D6499-16

Superseded Historical

Standard Test Method for The Immunological Measurement of Antigenic Protein in Natural Rubber and its Products

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ASTM F2212-19

ASTM F2212-19

Superseded Historical

Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)

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ASTM F1841-19

ASTM F1841-19

Superseded Historical

Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

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ASTM F719-20

ASTM F719-20

Superseded Historical

Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation

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ASTM F624-09(2024)

ASTM F624-09(2024)

Superseded Historical

Standard Guide for Evaluation of Thermoplastic Polyurethane Solids and Solutions for Biomedical Applications

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ASTM F3209-24

ASTM F3209-24

Superseded Historical

Standard Guide for Autologous Platelet-Rich Plasma for Use in Tissue Engineering and Cell Therapy

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